Oneness Biotech Co (合一) yesterday said it expects revenue to increase next year assuming its ON101 ointment is approved.
Oneness, which has submitted an application for the treatment for diabetic foot ulcers to the Food and Drug Administration (FDA), said its phase 3 clinical trial showed that 62.2 percent of people who were treated with ON101 showed improvement.
Among those with an ulcer between 5cm2 and 10cm2, 62.2 percent healed after treatment with ON101, compared with 16.7 percent for Aquacel, a company filing with the Taipei Exchange said.
The FDA on Dec. 9 conducted a technical review of Oneness’ application and asked it to deliver administrative data last week, meaning it passed the review, the most challenging phase of the approval process, the company said.
“The business opportunity for ON101 is considerable, as there are 2.27 million people with diabetes in Taiwan,” Oneness founder William Lu (路孔明) told an investors’ conference. “Among them, at least 60,000 have diabetic foot ulcers, as the occurrence rate is 2.6 to 5.5 percent.”
A person with diabetic foot ulcers spends about NT$140,000 (US$4,911) on medicine per year, while 22,000 people have been hospitalized and 6,500 undergone an amputation, Lu said, citing National Health Insurance data, adding that the financial burden totals NT$10.8 billion per year.
“As ON101 has better efficacy, we expect its launch to reduce the hospitalization and amputation rates, and reduce the financial burden patients face,” he said.
“Diabetic foot ulcers are the complication that people with diabetes have to spend the most on,” he said.
A 15g tube of ON101 is likely to cost US$670, which would help Oneness gain a 25 to 30 percent share of the US market, he said.
People with an ulcer smaller than 2cm2 would need two tubes to completely heal, while those with ulcers between 5cm2 and 10cm2 would need seven tubes, Oneness said.
Those costs would be lower than current treatments, it said.
It expects sales to continue rising next year after it obtains approval to market the ointment, Lu said.
Oneness reported cumulative revenue of NT$39 million for the first 11 months of this year, up 229 percent year-on-year.
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